510(k) Report

Devices descending from K223077

4 later devices reach ViewFlex Xtra ICE Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…Abbott Medical20252—
+1K251231ViewFlex™ X ICE Catheter, Sensor Enabled™Abbott Medical20250—
+2K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health20260—
+2K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.20250—